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Active, not recruitingNCT07201883Updated Oct 1, 2025

Chewing Gum vs. Ondansetron as Rescue Treatment for PONV in Female Patients

A Phase 1 interventional study of Ondansetron (Zofran) and chewing gum in Postoperative Nausea and Vomiting (PONV), sponsored by Makassed General Hospital. Active, not recruiting at 1 site in Lebanon. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-10-01.

Sponsored by Makassed General Hospital · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Feb 2026, 8 months ago, but the record still lists the study as active, not recruiting.
Phase
Phase 1
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years and older
Sex
Female
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Study summary

The proposed randomized clinical trial aims to test and compare the efficacy of chewing gum vs. Intravenous antiemetic ondansetron as rescue treatment for post-operative nausea and vomiting (PONV) among Lebanese female patients undergoing laparoscopic surgery in the post-operative anesthesia care unit (PACU).

Read the detailed description

Post-operative nausea and vomiting remains a significant complication following general anesthesia, particularly when volatile anesthetics are used. Previous studies, including a multicenter randomized trial conducted in Australia, have explored alternative treatment modalities for PONV. Chewing gum, a non-pharmacological intervention, has shown promise as a potential alternative or adjunct to conventional antiemetics like ondansetron. This study focuses on the Lebanese female population, aged 18 and above, who have undergone laparoscopic surgery under volatile anesthetic-based general anesthesia. This demographic is chosen based on established risk factors for PONV and may offer unique insights into efficacy within this subgroup.

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Conditions studied

  • Postoperative Nausea and Vomiting (PONV)

Keywords

  • PONV
  • Ondansetron
  • Postoperative Period
  • Vomiting
  • Laparoscopy
  • Antiemetics
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In context

Postoperative Nausea and Vomiting

638 studies on the registry are indexed under Postoperative Nausea and Vomiting; 110 are open to participants now.

This study's planned enrollment of 90 is below the median of 112 across 529 interventional studies indexed under Postoperative Nausea and Vomiting.

Browse Postoperative Nausea and Vomiting studies →

Lead sponsor

Makassed General Hospital is the lead sponsor of 39 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Females
  • Aged 18 and above,
  • Weight 40kg and above,
  • Who have undergone laparoscopic
  • Surgery under volatile anesthetic-based general anesthesia.

Exclusion criteria

Exclusion Criteria:

  • Have history of motion sickness,
  • Maintained anesthesia during surgery using Propofol-pump
  • Were given antiemetics within 8 hours pre-surgery
  • Allergy to ondansetron
  • Planned mechanical ventilation post-operation
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
90 participants (estimated)

Study arms

  • Active comparator
    Ondansetron

    Drug: Ondansetron (Zofran)

  • Experimental
    Chewing Gum

    Other: chewing gum

  • Sham comparator
    Ondansetron + Chewing Gum

    Combination Product: Ondansetron + Chewing gum

Interventions

  • 4 mg IV push

  • Otherchewing gum

    Peppermint sugar free chewing gum

  • Combination productOndansetron + Chewing gum

    Ondansetron 4 mg IV push Peppermint sugar free chewing gum

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What researchers measure

Primary outcomes

  1. Complete cessation of PONV with no recurrence and no rescue medication

    Time frame: 2 hours

Secondary outcomes

  1. Patient satisfaction

    Time frame: post-operative period ( up to 3 hours)

  2. Quantity of rescue treatment modalities used

    Time frame: immediately after PONV start until complete resolution of symptoms

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Study locations

1 site
  • Makassed General Hospital
    Beirut, Lebanon
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References and documents

Publications

  • Chernik DA, Gillings D, Laine H, Hendler J, Silver JM, Davidson AB, Schwam EM, Siegel JL. Validity and reliability of the Observer's Assessment of Alertness/Sedation Scale: study with intravenous midazolam. J Clin Psychopharmacol. 1990 Aug;10(4):244-51. PubMed 2286697 ↗

Related links

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 1, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07201883
Lead sponsor
Makassed General Hospital
Responsible party
Omar Rajab (Chairman of Anesthesia Department, Makassed General Hospital) — Principal investigator
First posted
Oct 1, 2025
Start date
Aug 22, 2025
Primary completion
Feb 28, 2026 (estimated)
Completion
Feb 28, 2026 (estimated)
Last update
Oct 1, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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